Quality Considerations for MAM for Therapeutic Proteins

The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based peptide mapping approach used for the identification and quantitation of product quality attributes (PQAs) in therapeutic proteins.

The U.S. FDA Center for Drug Evaluation and Research (CDER), Emerging Technology Program (ETP) has assessed the use of MAM in quality control environments and laboratory resources have been developed to improve the FDA’s understanding of the approach.

This meeting will discuss:

• How the LC-MS based multi-attribute method can be used for quality control of therapeutic proteins
• How the multi-attribute method can detect multiple product quality attributes or critical quality attributes within a single LC-MS run
• Key considerations for implementation of the multi-attribute method, including risk assessment, method validation, new peak detection, and conventional method comparisons

For advance registration, please visit the MAM for Therapeutic Proteins meeting page